Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age

PHASE4CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 28, 2015

Primary Completion Date

July 29, 2025

Study Completion Date

July 29, 2025

Conditions
Hunter Syndrome
Interventions
DRUG

Elaprase for intravenous (IV) infusion

Patients enrolled in this study will receive once-weekly IV infusions of Elaprase at a dose of 0.5 mg/kg and will be followed for a minimum of 5 years after initiation of Elaprase treatment, or until they reach their 10th birthday, whichever is longer.Height and weight data from HOS will be utilized in the Primary Growth Analysis for this study.

Trial Locations (8)

1000

Philippine General Hospital, Manila

10101

Hospital Infantil Dr Robert Reid Cabral, Santo Domingo

10330

Chulalongkorn University, Bangkok

11000

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic, Belgrade

50586

Hospital Kuala Lumpur, Kuala Lumpur

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

Unknown

National Pediatrics Hospital, Hanoi

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Shire

INDUSTRY